RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18

K091507 · Rayner Intraocular Lenses , Ltd. · MSS · Dec 4, 2009 · Ophthalmic

Device Facts

• Record ID: K091507
• Device Name: RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18
• Applicant: Rayner Intraocular Lenses , Ltd.
• Product Code: MSS · Ophthalmic
• Decision Date: Dec 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The disposable single use soft tipped small incision injector (model number R-INJ-04/18) is intended to be used to compress and insert into the capsular bag only those IQL models that allow use of this injector in their approved labelling.

Device Story

Single-use, disposable mechanical injector for cataract surgery. Device facilitates folding and insertion of intraocular lenses (IOLs) into the capsular bag through a 1.8mm incision. Operator (physician) manually loads the IOL into the injector's loading bay using forceps, applies viscoelastic lubricant, and closes the flaps to fold the lens. Plunger is advanced manually to push the folded lens through the nozzle into the eye. Device is intended for use only with IOL models specifically labeled for compatibility. Benefits include controlled, small-incision delivery of IOLs, reducing surgical trauma.

Clinical Evidence

Bench testing only. Mechanical testing was performed to verify that the injector functions according to design requirements and safely delivers the IOL.

Technological Characteristics

Single-use, disposable manual injector. Barrel, flap, nozzle, bush, and sleeve constructed of polypropylene; plunger constructed of polycarbonate. Designed for 1.8mm incision cataract surgery. Mechanical operation via manual plunger advancement. Non-powered, non-electronic.

Indications for Use

Indicated for use by physicians to compress and insert intraocular lenses (IOLs) into the capsular bag during cataract surgery, specifically for IOL models approved for use with this injector.

Regulatory Classification

Identification

An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.

Predicate Devices

• Rayner Single Use Soft Tipped Disposable injector R-INJ-04 (K062512)

Submission Summary (Full Text)

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K09, ISD 7

Rayner Intraocular Lenses Limited

Sackville Road

Hove
East Sussex
BN3 7AN

Telephone: [phone]
Fax: [phone]

# 510(k) Summary as required by 21 CFR 807.92

DEC - 4 2009

#### Submitted by

r

Rayner Intraocular Lenses Limited Address as letterhead Establishment registration: 9611165

Contact person: Roy Kemaghan Regulatory Affairs Manager Telephone # [phone] Fax # [phone] Email: [e-mail]

Summary propared on May 18, 2009

### Device Information

- · Trade/Proprietary Name: Rayner Single Use Small Incision Disposable Injector R-1NJ-04/18
- · Common Name: Rayner Single Use Small Incision Injector
- · Classification: Product Code is MSS. CRF section is TITLR 21. Part 886. Subpart E. Scc. 886.4300 Intraocular Lens guide. Device is Class I. Classification panel is Ophthalmic

### Information on devices to which substantial equivalence is claimed

- 510(k) Number: K062512
- · Trade or Proprietary or Model Name: Rayner Single Use Soft Tipped Disposable injector R-INJ-04
- Manufacturer: Rayner Intraocular Lenses Limited

#### Intended Use

The single use small incision disposable injector (model number R-INJ-04/18 is intended to be used to compress and insert into the capsular hag only those Intraccular Lenses that allow use of this injector in their approved labelling.

Description of the device that is subject to of this application, including an explanation of how the device functions, basic scientific concepts, scientific, physical and performance characteristics (design, material, physical properties)

The single use small incision disposable injector (model number R-INJ-04/18 is intended to be used to compress and insert into the capsular bag only those intraocular Lenses that allow use of this injector in their approved labelling. It is designed to mechanically fold the lens and insert it into the eye during normal, small incision (1.8mm) cataract surgery,

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#### INJECTOR LOADING is described as follows:

Aseptically transfer the injector to the sterile fiche by upping it from the tray. Fully retract the plunger ensuring the tip does not protrude into the loading bay. Open the loading bay flup fully to 900 and sparingly apply a commercially available viscoelastic inside the norzele and to both grooves of the loading bay. Balanced salt solution alone should not be used as a lubricant. Carcfully pocl back the foil lid of the lens blister. Gently lift out the lens using parallel lipped, non serrated forcens e.g. Kelman-McPherson. Rinse the Intraccular Lens with sterile balanced salt solution. Position the lens in the injector loading bay in a "reverse S" configuration. Ensure that the nearest edge of the ontic is securely under the edge (lip) of the harrel. Hold open the flap and press down on the lens with closed forceps to ensure that the furthest edge of the optic is securely under the edge (lip) of the flap. Ensure that the haptics are completely within the loading bay. While keeping the lens in position with open forceps, gently close the flaps of the injector ensuring that no part of the optic or haptics is trapped. hefore locking the flaps firmly logether. Visually observe that the lens is symmerrically folded within the loading bay. Advance the plunger in a slow controlled manner. Anticipate an initial stight resistance. Excessive resistance could indicate a trapped lens. Observe that the lens stays symmetrically folded within the nozzle. When the lens exits the nozzle, stop depression the planger. The plunger is only to be depressed once.

· The small incision injoctor (model number R-1NJ-04/18 is a plastic single use disposable device.

The injector components harrel, flap, nozzle, bush and sleeve are made of polypropylene. The plunger is made of polycarhonate. The injector is transparent and the plunger is white.

#### Summary of Testing

The Single Use Soft Tipped Disposable Injector R-INJ-04/18 was designed, developed and tested according to written procedures. Mechanical testing was completed to ensure that the injector functioned according to the requirements. The test results support a determination of substantial equivalence.

#### Conclusions

The Single Use Soft Tipped Disposable Injector R-INJ-04/18 has exactly the same intended use as the predicate device, using a smaller incision and essentially has identical technological characteristics. Minor changes in the dimensions of the injector norzhe do not raise any new questions regarding safety of effectiveness of the device. The R-INJ-04/18 Injector performs as intended and presents with no unacceptable risks to the intended patient population or end user. The R-IN3-04/18 is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Rayner Intraocular Lenses Limited c/o Mr. Roynan H. Kernaghan Sackville Road Hove East Sussex BN3 7 AN England

DEC - 4 2009

Re: K091507

Trade/Device Name: Rayner Single Use Soft Tipped Small Incision Disposable Injector R-INJ-04/18

Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: II Product Code: MSS Dated: October 1, 2009 Received: October 5, 2009

Dear Mr. Kernaghan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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### Page 2 - Mr. Roynan H. Kernaghan

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdaggv/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerere, yours,

Kesia Alexander for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Rayner R-IJN-04/18 Single Use Small Incision Disposable IOL Injèctor

## INDICATIONS FOR USE

510(k) Number (if known): K091507

#### Device Name: Rayner Single Use Soft Tipped Small Incision Disposable Injector R-INJ-04/18

Indications For Use:

### Statement of Indications for use

"The disposable single use soft tipped small incision injector (model number R-INJ-04/18) is intended to be used to compress and insert into the capsular bag only those IQL models that allow use of this injector in their approved labelling."

Federal U.S. Law restricts this device to sale by, or on the order of a physician.

Prescription Use _Yes__√ No. V

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anna Postell

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number *K091507*

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May 5th 2009